Kornimate/medical-research-clean huggingface dataset:
n-acetylcysteine augmentation in treatment-refractory obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: obsessive-compulsive disorder (ocd) affects 2-3% of the population and leads to a great deal of suffering. many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. however, 20-30% of patients get minimal benefit from these established therapeutic strategies. new avenues of treatment are urgently needed. existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of ocd. the researchers are therefore interested in using medications that target glutamate as novel treatment options for those ocd patients who do not benefit from established treatments. one such medication is the drug n-acetylcysteine, whose glutamatergic antagonistic properties may be effective in reducing the glutamatergic hyperactivity that is thought to contribute to the pathophysiology of ocd and major depressive disorder (mdd). riluzole, which is fda approved for amyotrophic lateral sclerosis (als, or lou gehrig's disease) is also a glutamatergic agent. there is evidence that riluzole possesses anti-depressant, anti-obsessional, and anti-anxiety properties. the modulation of glutamatergic activity is a promising new approach to the treatment of mood disorders. the researchers are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of n-acetylcysteine, added to whatever other ocd medications they are taking.

due to limited participation, this study has closed.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of ocd, confirmed by scid-iv; symptoms of at least 1 year duration * moderate to severe ocd symptoms (y-bocs \> 16) * documented failure of an adequate trial of an ssri * agreement to engage in a reliable form of birth control (women only) exclusion criteria: * primary diagnosis of a psychotic disorder * active substance abuse or dependence * unstable medical condition * prior exposure to n-acetylcysteine * prior psychosurgery * pregnancy, breastfeeding, or intent to become pregnant during study * liver function tests (lfts) elevated to more than 2x the upper limit of normal * evidence of active liver disease * seizure disorder * active suicidal ideation

Keywords: obsessive-compulsive disorder ocd glutamate n-acetylcysteine augmentation
effects of vildagliptin/metformin combination on markers of atherosclerosis, thrombosis, and inflammation in diabetics with coronary artery disease

Conditions: Type 2 Diabetes Mellitus; Ischemic Heart Disease

Summary: the purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is associated with clinically significant reductions in biological markers of inflammation, pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a population of diabetic patients with coronary artery disease who undergo cardiac rehabilitation. the pre-specified established biological markers of inflammation, pro-thrombogenicity, and atherosclerosis will include: interleukin-6 (il-6 - primary biological marker), hs-crp, platelet reactivity testing, mmp-9, interleukin 1 beta (il-1 beta) and adiponectin levels.

the study is designed as a single-center, randomized, non-blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. we plan to prospectively enroll 60 patients with proven coronary artery disease and randomize them in a 2:1 ratio to either vildagliptin-metformin therapy (n=40) or metformin therapy (n=20).

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus on oral mono-therapy or diet only treatment * stable documented ischemic heart disease (\>30 days post ami, cabg or pci) * sub-optimal hb a1c as defined ≥6.5% * age \> 21 * life expectancy \>1 year exclusion criteria: * significant renal impairment (creatinine ≥1.4 mg\\dl females or ≥1.5 mg\\dl males) * planned coronary intervention or planed surgical intervention (pci or cabg) * planned surgical intervention * recent (\<30 day) acute coronary syndrome (acs) * hypersensitivity to either of the study drug components * history of lactic acidosis * type i diabetes * current hb a1c \>9% * current insulin treatment * active treatment with glp-1 or dpp4i medication * hepatic impairment or alt\\ast elevations beyond x2 upper normal limit or known hepatic failure * inability to comply with study protocol * active malignancy other than basal cell carcinoma (bcc) * clinically advanced congestive heart failure - nyha iii-iv * severe left ventricular dysfunction (lvef\<30%) with nyha ii or any nyha class with documented recent heart failure decompensation (\<3 months) * severe stable cardiac angina ccs iii - iv or unstable angina * chronic inflammation (i.e. ibd, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection) * pregnancy, lactation or child-bearing potential

Keywords: type 2 diabetes mellitus vildagliptin metformin atherosclerosis inflammation interleukin-6 tnf atherothrombosis adiponectin mmp-9 hs-crp
a long-term study of de-114 ophthalmic solution in patients with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: safety and efficacy of de-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.


Eligibility criteria:
inclusion criteria: * provided signed, written informed consent. * has a positive result from a type i allergy test. * if a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * presence of any abnormality or significant illness that could be expected to interfere with the study.
evaluation of tiotropium 2.5 and 5 mcg once daily delivered via the respimat® inhaler compared to placebo in 1 to 5 year old patients with persistent asthma

Conditions: Asthma

Summary: the primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ics) treatment.


Eligibility criteria:
inclusion criteria: 1. all patients' parents (or legal guardians) must sign and date an informed consent consistent with ich-gcp guidelines and local legislation prior to participation in the trial. where appropriate, participants should assent to enroll in the study. 2. male or female patients between 1 and 5 years of age. 3. by a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms) 4. for patients aged 5 years and capable of performing technically acceptable pulmonary function tests (pfts): documented impaired lung function (i.e. pre-bronchodilator forced expiratory volume in 1 second (fev1) is smaller or equal to 90% of predicted normal). 5. all patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before visit 1. 6. all patients must be symptomatic (partly controlled) as defined by the global initiative for asthma (gina) guideline for children aged 5 years and younger in the week prior to visit 1 (screening) and in the week prior to randomisation (visit 2). further inclusion criteria apply. exclusion criteria: 1. patients with a significant disease other than asthma. 2. patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1. 3. patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year. 4. patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year. 5. patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy. 6. patients with clinically significant lung diseases other than asthma. 7. alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath. 8. patients with known active tuberculosis. 9. patients who have undergone thoracotomy with pulmonary resection. 10. patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (visit 1). further exclusion criteria apply.
social networking on mobile phone to improve maternal and neonatal outcomes

Conditions: Premature Birth

Summary: the purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.

health education intervention with social networking (hisonet) is a open-label randomized controlled trial. the objective of this study is to determine the efficacy of social networking media on mobile phone intervention in antenatal care (anc) group-health education compared with usual anc health education. the incidence of preterm delivery and major neonatal morbidity including respiratory distress syndrome, stillbirth and perinatal mortality in women delivering from 28 to 36 weeks' gestation are significant outcomes in a randomized prospective design. preterm delivery occurs in approximately 9.6% as global incidence, and about 11.1% in south-eastern asia. forty-four percent of child under 5 years died in neonatal period. preterm birth is one of the three leading causes of neonatal death which 15% died from preterm birth complications such as respiratory distress syndrome, intraventricular hemorrhage, necrotizing entercolitis, and sepsis. recent studies demonstrate that short message service (sms) on mobile phone intervention in antenatal care can increase numbers of anc attendance to who recommendation of four or more visits and decrease in perinatal mortality. social networking on mobile phone has been increasingly used in daily life of both healthcare personnel and women who attend anc clinic. however, there is lack of evidence that demonstrates the effect of social networking on mobile phone to improve maternal and neonatal outcomes. line, a mobile application, is a popular one of many social networking applications. so, health education through line of antenatal women about serious complications such as labor pain, bleeding, water breaking and fewer fetal movement during pregnancy may encourage them to come to the hospital as early as possible. early diagnosis of premature labor provides early management and better maternal and neonatal outcomes. so, a randomized controlled trial should be conducted to answer these questions.

Eligibility criteria:
inclusion criteria: * women who attend antenatal care clinic and have intention to deliver at the study hospital. * thai race * participant or husband or relatives is an owner of mobile phone with social networking application exclusion criteria: * participant is known by other one in different study arm (contamination) * cannot be assess on wel-being about privacy, delivery failure and misinterpretation of media via social network after complete study

Keywords: social networking mobile phone antenatal care health education maternal outcome neonatal outcome
cardiac output changes during hyperbaric and isobaric bupivacaine in patients undergoing cesarean section

Conditions: Cardiac Output; Hypotension; Anesthesia, Spinal

Summary: spinal block leads to the reduction of systemic vascular resistance (svr) which may effect the cardiac output. ngan kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine


Eligibility criteria:
inclusion criteria: * american society of anesthesiology classification i - ii * elective or urgency cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane * singleton pregnancy * body mass index \< 40 kg/m2 exclusion criteria: * pregnancy \<35 weeks gestational age * hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia * history of allergy to the study drugs

Keywords: isobaric marcaine hyperbaric marcaine
a study to collect data about analgesia in patients with bone metastasis

Conditions: Bone Metastasis

Summary: up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. all patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the investigator based on their needs. during their regular visits to the investigator, patients will complete questionnaires and clinical pain assessments.


Eligibility criteria:
inclusion criteria: * patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations. * patients having been or being treated for their bone metastasis and/or their primary cancer. * patients who require analgesic treatment for unsatisfactory pain relief. * patients will be required to score at least 4 on the waps 11-point nrs during the week preceding enrollment. * patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days. * are men or women of at least 18 years of age. * are reliable and willing to make themselves available for the entire duration of the study and are willing to follow study procedures. * have given written informed consent approved by the relevant ethics committee governing the study site. exclusion criteria: * patients having had a major surgery within 28 days prior to signing informed consent document or planning to have a major surgery during the study. * patients having a life expectancy \< 3 months according to investigator judgment. * patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study. * patients with a current or recent history unrelated to their cancer condition, as determined by the investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study. * patients having a karnofsky performance status below 70% or who score (eastern cooperative oncology group (ecog)/zubrod score) above 1. * are investigator site staffs directly affiliated with this study and/or their immediate families. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient. * patients under legal protection, according to the country law. * patients currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
atacicept in anti-tumor necrosis factor alpha-naïve subjects with rheumatoid arthritis (august ii)

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (ra), inadequate response to methotrexate (mtx) and no previous exposure to anti-tumor necrosis factor alpha (anti-tnfalpha) therapy.


Eligibility criteria:
inclusion criteria: * male or female subjects greater than or equal to (\>=) 18 years of age at the time of informed consent who have ra satisfying american college of rheumatology (acr) criteria with a disease history of at least 6 months * subjects must have active disease, defined by \>=8 swollen joints (out of 66), \>=8 tender joints (out of 68) and crp \>=10 milligram per liter (mg/l) and/or erythrocyte sedimentation rate (esr) \>=28 millimeter per hour (mm/hr), despite treatment with mtx at a dose of \>=15 milligram per week (mg/week) for greater than (\>) 3 months * other protocol-defined inclusion criteria could apply exclusion criteria: * inflammatory joint disease other than ra * previous or concurrent treatment with any approved or investigational biological compound for ra, including but not restricted to any anti-tnfalpha agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (il-1ra) and belimumab * treatment with disease-modifying anti-rheumatic drug (dmards) other than mtx * participation in any interventional clinical trial within 1 month before study day 1 * mtx dose \>25 mg/week, prednisone dose \>10 mg/day (or equivalent), or change in steroid or non-steroidal anti-inflammatory drug (nsaid) dosing regimen within 28 days before study day 1 * immunization with live vaccine or immunoglobulin (ig) treatment within 28 days before study day 1 or need for such treatment during the study (including follow-up) * any history or presence of active or latent tuberculosis, major infection requiring hospitalization or intravenous anti-infectives within 28 days before study day 1 * other major concurrent illness or organ dysfunction as specified in the protocol * serum igg below 6 gram per liter (g/l) * known hypersensitivity to atacicept or to any of the components of the formulated atacicept * other protocol-defined exclusion criteria could apply

Keywords: rheumatoid arthritis atacicept adalimumab humira®
fenofibrate and pharmacogenetic impact in dyslipidemia

Conditions: Dyslipidemia

Summary: the purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and fda (food and drug administration) approved medication for lowering triglycerides and cholesterol. the hypothesis: the pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication-fenofibrate.

the investigators seek to screen over 200 subjects for select candidate genes to serve as a source of subjects which may participate in a genotype guided investigation as to the predictability of response based on genotype. response endpoints relate to lipid parameters and other variables of interest to cardiovascular endpoints. subjects with genotypes of interest would then be enrolled into a short term clinical trial evaluating their response to fenofibrate based on their genetic profile ascertained from the screening phase.

Eligibility criteria:
inclusion criteria: * 18-75 year old * be willing to participate in the study and attend the scheduled clinic exams * consent to taking lipid lowering therapy for 4 weeks and if necessary discontinue lipid lowering agents for a period of 8 weeks exclusion criteria: * \<18 years of age * history of liver, kidney, pancreas, pancreatitis, gall bladder disease or malabsorption (crohn's disease etc.) * use of insulin or currently taking warfarin * pregnant women or women of childbearing potential not using an acceptable form of contraception * history of an allergy or hypersensitivity to fenofibrate * investigational drug use within 30 days of the study * a disease that, in the opinion, of the pi, would put the subject at risk during the study
treatment of infected pulp in primary teeth with a mixture of calcium hydroxide and gingerols

Conditions: Primary Teeth; Pulp Necroses; Infected Pulp; Root Canal Treatment

Summary: this study was conducted to evaluate calcium hydroxide mixed with gingerols versus metapex in treatment of primary teeth with infected necrotic pulp

study compare calcium hydroxide mixed with gingerols versus metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

Eligibility criteria:
inclusion criteria: 1. the cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments. 2. parents signed the consent to participate in the study. 3. absence of any systemic disease, which would contraindicate pulp therapy. 4. child didn't have any history of a sensitive reaction to any component of used materials. 5. present half to two third of tooth root or more 6. root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment. exclusion criteria: all that does not correspond to inclusion criteria.

Keywords: pediatric dentistry pulpectomy infected pulp necrotic pulp gingerols calcium hydroxide metapex ginge-cal
clinal evaluation of navigation based functional ear surgery using image guided and robotically assisted techniques

Conditions: Sensorineural Hearing Loss

Summary: to assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based hearo procedure and subsequently insert the electrode array of the cochlear implant through the access.

* demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults. * validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation. * validate the system and procedure safety mechanisms. * collect required data for validation of safety algorithms and procedure workflow optimisation. * validate the hearo system.

Eligibility criteria:
inclusion criteria: * patients suffering from profound sensorineural deafness requiring a cochlear implant exclusion criteria: * age under 18 years * pregnant women * anatomical anomalies of temporal bone * chronic otitis media with or without cholesteatoma

Keywords: robot image guidance cochlear implantation navigation hearo procedure sensorineural hearing loss inner ear access